Financial Data and Key Metrics Changes - The company reported a combined revenue of $19.8 million for Q1 2025, with Hebsado sales in the U.S. contributing $18 million and ChemoSAT sales in Europe adding $1.8 million, compared to $2 million and $1.1 million respectively in Q1 2024 [5][15] - Gross margins improved to 86% in Q1 2025 from 71% in the same period last year [15] - Net income for Q1 2025 was $1.1 million, a significant turnaround from a net loss of $11.1 million in Q1 2024 [16] - Positive adjusted EBITDA for Q1 2025 was $7.6 million, compared to an adjusted EBITDA loss of $7.3 million in Q1 2024 [16] - The company ended the quarter with approximately $59 million in cash and investments, and positive operating cash flow of $2.2 million [16] Business Line Data and Key Metrics Changes - The company activated 19 treatment centers in the U.S. by the end of Q1 2025, with plans to reach 30 active centers by year-end [6][7] - Average treatments per center were approximately two per month in Q1, with expectations to remain just under two for the remainder of the year [8][27] Market Data and Key Metrics Changes - The European market for ChemoSAT experienced a 29% growth over the prior quarter, reaching $1.8 million, although it is not expected to be a significant revenue contributor in the short to medium term [9] - The company is focusing on expanding its presence in the U.S. market while managing reimbursement challenges in Europe [9][40] Company Strategy and Development Direction - The company aims to leverage cash from operations to support research and development initiatives for Hebsado beyond metastatic uveal melanoma patients [6] - The strategy includes expanding treatment centers and enhancing access for patients through the Hepcido KidAccess 360 platform [8] - The company is pursuing additional clinical trials for liver-dominant metastatic colorectal and breast cancer, with FDA clearance received for both trials [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the goal of 30 active centers by year-end, with a balanced approach to center activations throughout the year [22][24] - The company anticipates that the average monthly treatment per site will stabilize just under two for the remainder of the year due to the pace of new center activations [27] - Management highlighted the importance of clinical demand and engagement with oncologists and interventional radiologists in driving revenue growth [13] Other Important Information - The company has no outstanding debt obligations and has successfully raised $16.2 million through the exercise of Series F warrants [16][17] - The company is managing its European operations on a breakeven basis while focusing on generating clinical data [43] Q&A Session Summary Question: Update on center activations and expectations for Q2 - Management indicated that center activations may be more evenly distributed throughout the year than previously anticipated, with potential for two to three additional centers in Q2 [20][24] Question: Treatment frequency and center performance - Average treatment frequency is expected to stabilize around 4.1 treatments per patient, with a mix of organic and referred patients contributing to center performance [35][86] Question: R&D expenses and EBITDA expectations - R&D expenses are expected to increase significantly, with EBITDA margins projected to remain positive throughout the year despite rising operational costs [29][30] Question: European market growth and reimbursement - Management noted that while the European market is growing, reimbursement challenges remain, and additional resources will be allocated once reimbursement is secured [39][42] Question: Companion diagnostics and potential acquisitions - The company is open to exploring companion diagnostics or synergistic products but has not identified any suitable opportunities at this time [70][72]
Delcath(DCTH) - 2025 Q1 - Earnings Call Transcript